Actinogen Medical Ltd (ASX: ACW) shares are tumbling today after the company released its quarterly activity report and strategic update this morning. At the time of writing, the Actinogen share price is sliding a whopping 17.24% to 4.8 cents.
Actinogen is a biotechnology company that develops drugs for Alzheimer's disease and the cognitive decline associated with other neurological and metabolic diseases. Geographically, it operates in and derives revenue from Australia.
The company's main product is called Xanamem. Xanamem is a brain-penetrant, small-molecule enzyme inhibitor that works to inhibit excess cortisol production inside brain cells.
What Actinogen's quarterly report stated
Actinogen shares have fallen off a cliff today following the release of the company's latest updates. Actinogen advised that it continues to focus on the development of its lead drug, Xanamem, as a treatment for multiple indications. According to the company, it is leveraging the positive phase I XanaHES results, in which a significant improvement in multiple cognition domains was achieved in healthy older volunteers.
Now the company is seeking to progress its Xanamem treatments into an Alzheimer's population with a phase II XanaMIA trial planned to target patients with mild cognitive impairment due to Alzheimer's Disease.
In its update, the company advised that whilst it has "data supporting [the] efficacy of Xanamem in doses as low as 5mg" part of the phase II study's purpose will be to confirm the dose.
The company's uncertainty surrounding the drug's dosage could be a potential reason investors are driving down the Actinogen share price today. Actinogen has advised it will hold a shareholder teleconference on 23 April during which it will provide an update on the company's "dose ranging study seeking to confirm [the] minimum effective Xanamem dose".
In parallel, Actinogen remains focused on progressing study planning for anxiety, sleep and behavioural problems in Fragile X syndrome (FXS). These symptoms have a substantial impact on day-to-day functioning of patients and their carers and there are currently no approved treatment options that specifically target these symptoms associated with FXS.
Actinogen says it is "well advanced" with the planning for its Phase II XanaFX, with the trial expected to commence in the second half of this year.
During the quarter, Xanamem was also awarded a Rare Paediatric Disease Designation (RPDD) for Xanamem in the treatment of FXS in patients under the age of 18. The RPDD program is designed to incentivise the development of drugs for rare childhood illnesses, such as FXS, with potential clinical, development and commercial benefits.
Management comments
Actinogen CEO and MD Steven Gourlay was upbeat about the company's ability to deliver future shareholder value, saying:
After many years of working in the biopharma industry, I am excited by the huge potential of Actinogen. In my last major role at Principia Biopharma as Chief Medical Officer, I steered two small molecules from a microcap company valuation, through successful Phase II development and into Phase III, resulting in a significant value appreciation for shareholders when the company was acquired for US$3.7B.
I find Actinogen to be a similar investment opportunity: excellent science, a promising Phase II molecule for multiple indications, with an attractive valuation, and so accepted the role as CEO / MD, and personally invested over A$300K into the Company prior to my appointment. We are now planning for multiple shots on goal and strongly believe the upcoming trials are designed to achieve informative and positive outcomes. I look forward to working with the team to further develop Xanamem as we progress the development pipeline.
Actinogen share price snapshot
Following today's releases, the Actinogen share price is falling against its 52-week high of 6.2 cents set on Monday this week. Actinogen shares are up from just over two cents per share at the beginning of March. The company has a current market capitalisation of around $96 million.
